METAXALONE

Product NDC
61919-346
11-digit product format
619190346
Labeler code
61919
Product ID
61919-346_9c98e95a-0c4d-8598-e053-2995a90a131e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METAXALONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
NDA013217
Marketing category
NDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe1c2a6-5488-f909-3872-734054eb745aProduct name520181231
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4Product name120150615
68c52498-c9cb-48ab-a792-a4876149361eProduct name120150409

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-346-302023-01-30C16284748780-1f386c649-db7b-0266-e053-dadaa90a7c1aMETAXALONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-346-30METAXALONE30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-346-30EA - Each61919-346e1a059c9-5a04-49f2-82e3-3e2d0f5fcaa712014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YMETAXALONE TABLET [DIRECT RX]1
METAXALONEACTIVE MOIETY1NMA9J598YMETAXALONE TABLET [DIRECT RX]1
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZMETAXALONE TABLET [DIRECT RX]1
CALCIUM ALGINATEINACTIVE INGREDIENT8P20S56HZIMETAXALONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METAXALONE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETAXALONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-346METAXALONE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200121_61fc1a6a-ecfd-4467-b172-a11bebbc32d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN61fc1a6a-ecfd-4467-b172-a11bebbc32d33
351254metaxalone 800 MG Oral TabletSCD61fc1a6a-ecfd-4467-b172-a11bebbc32d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-346-306191903463030 TABLET in 1 BOTTLE (61919-346-30) 30 tablet2015-01-010000-00-00NoNoCurrent